NCT04245150

Assessing the Impact of the Microbiome on Breast Cancer Radiotherapy Toxicity

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 23 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: —

Summary

Microorganisms in the human body (such as virus, bacteria, fungus) may have an important role in breast cancer side effects. In this study, microorganisms will be analyzed to determine which, if any,are present. It will then be determined if side effects from breast radiation are associated with these microorganisms. Understanding the association of microorganisms with side effects will allow the study team to look at strategies to reduce side effects for patients undergoing radiation to the breast.

Detailed description

This study will prospectively enroll 50 participants with with biopsy proven Ductal carcinoma in situ (DCIS) or invasive breast cancer 18 years of age or older, undergoing breast conserving surgery and adjuvant radiation therapy at Cleveland Clinic. Each participant will have a post-surgery pre-radiotherapy stool and breast skin sample obtained, complete a medical record review for clinical data, and have complete an interview/questionnaire in order to learn about potential risk factors which will be included in the data collection form. Included information will include Stage (T, N, M, composite), receipt of chemotherapy, radiation fields and dose, BMI, hypertension (HTN), Diabetes Mellitus (DM), smoking status, history of breast infection yes/no (Data Collection Form).

Conditions

• DCIS
• Invasive Breast Cancer

Interventions

Type	Name	Description
OTHER	Stool sample	Stool sample
OTHER	Skin Swab Sample	Skin Swab Sample

Timeline

• Start date: 2019-03-21
• Primary completion: 2024-07-30
• Completion: 2024-07-30
• First posted: 2020-01-28
• Last updated: 2024-09-19

Locations

1 site across 1 country: United States